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Kim Kardashian has put out a corrected Instagram post about a morning sickness drug she’s promoting, which the FDA had ordered taken down because it failed to mention the drug’s health risks.
“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. [My doctor] prescribed me #Diclegis. I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby,” Kardashian wrote to her 42 million Instagram followers. She also tweeted the post to her more than 34 million followers on Twitter.
But in a letter dated August 7, the FDA ordered that the drug’s manufacturer, Duchesnay USA, take the post down.
“The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts,” the letter reads.
Kardashian’s updated post, below, read in part: “I guess you saw the attention my last#morningsicknesspost received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.”
#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
DICLEGIS is intended for the treatment of nausea and vomiting in pregnant women who do not respond to other ways of managing these symptoms. But the drug has not been studied in women with severe morning sickness, or hyperemesis gravidarum, and is not recommended for women taking certain kinds of allergy medications or antidepressants.
The drug also comes with a warning about activities requiring mental alertness, and the most common side effect is drowsiness.
The FDA’s letter called for Duchesnay to “immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce,” as well as a written response describing how it will spread “truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”
Laney Landsman, a spokeswoman for Duchesnay, confirmed that Kardashian’s posts had been removed immediately, The Washington Post reported.
Given the fact that you can only convey a certain amount of information in a given space, social media poses a challenge for accurately communicating information about drug safety. And due to safety disclosure requirements, a lot of companies have steered clear of using it entirely.
But that doesn’t stop individuals from spreading questionable information.
“Outside of a promotional context, Kim Kardashian, if she jumped on Twitter and made these statements, and had absolutely no relationship to the company, that would be fine,” Kevin Madagan, counsel at Reed Smith, told the Post. However, “You need to be careful about how you go about doing it,” he said.